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Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

This study has been terminated.
(inability to find qualifying participants)
Sponsor:
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00719537
First received: July 17, 2008
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.

Condition Intervention
Preeclampsia Drug: Aspirin Drug: Placebo Oral Tablet Drug: Progesterone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by John Uckele, William Beaumont Hospitals:

Primary Outcome Measures:
  • Incidence of Preeclampsia [ Time Frame: second and third trimester of pregnancy ]
    Number of Participants with preeclampsia in second and third trimester of pregnancy.


Enrollment: 3
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Aspirin plus Placebo Oral Tablet
Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
Drug: Aspirin
Aspirin 81 mg once a day
Drug: Placebo Oral Tablet
Placebo 1 tab Daily
Active Comparator: Aspirin plus Progesterone
Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
Drug: Aspirin
Aspirin 81 mg once a day
Drug: Progesterone
Oral Progesterone 200 mg Twice Daily

Detailed Description:

Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.

Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. Human Leukocytes Antigen-G (HLA-G) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.

In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy.
  • 18 to 45 years of age will be included.

Exclusion Criteria:

  • Patients with chronic hypertension
  • children (age < 17 years)
  • Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors
  • patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719537

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
John Uckele
Investigators
Principal Investigator: John E Uckele, MD William Beaumont Hospitals
  More Information

Responsible Party: John Uckele, Medical Doctor, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00719537     History of Changes
Other Study ID Numbers: 2008-054
Study First Received: July 17, 2008
Results First Received: November 2, 2016
Last Updated: March 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No study data is available, will not be shared.

Keywords provided by John Uckele, William Beaumont Hospitals:
preeclampsia
progesterone
aspirin
prevent
soluble fms-like tyrosine kinase (sFlt-1)
Placental Growth Factor (PlGF)
risk

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Aspirin
Progesterone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 19, 2017